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Evaluation of a Parent-Infant Interaction Model (LiMoNid)

L

Linköping University (LiU)

Status

Completed

Conditions

Premature Birth

Treatments

Behavioral: LiMoNid

Study type

Interventional

Funder types

Other

Identifiers

NCT02034617
LinkoepingU

Details and patient eligibility

About

When becoming a parent of a preterm infant there is an increased risk of stress. There are a number of studies showing that parental stress has a negative impact on their engagement with their child. Other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. Structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions.

The investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. The observational program is called LiMoNid. Our hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. They will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. Parental stress may also be reduced by increased understanding and control. Regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. The emotional regulation should be strengthened by such an intervention.

The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child interaction.

Full description

The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.

Enrollment

140 patients

Sex

All

Ages

Under 96 hours old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Preterm infants born 30-36 weeks gestational age without known major malformations or complications
  • Families living in the county of Ostergotland, Sweden
  • Swedish speaking parents
  • Single or duplex birth

Exclusion criteria

  • Complications encountered during hospital stay that are known to affect cognition

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

Standard care
No Intervention group
Description:
The family receive standard care when enrolled in the Neonatal intensive care unit
Observation
Experimental group
Description:
The family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid.
Treatment:
Behavioral: LiMoNid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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